Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization

Neurological Stereotaxic Instrument

Brainlab AG

The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization.

Pre-market Notification Details

Device IDK211544
510k NumberK211544
Device Name:Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization
ClassificationNeurological Stereotaxic Instrument
Applicant Brainlab AG Olof-Palme-Str. 9 Munich,  DE 81829
ContactChiara Cunico
CorrespondentChiara Cunico
Brainlab AG Olof-Palme-Str. 9 Munich,  DE 81829
Product CodeHAW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-19
Decision Date2021-11-03

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